Lepzi Biotechnology Ltd. is based in Metro Vancouver, Canada, and is the R&D centre with highly qualified professionals in the design and development of point-of-care medical devices, from early-stage prototyping and reagent development to delivering products ready for registration and commercialization.
Lepzi Diagnostika Ltd. is based in Sofia, Bulgaria and is our European Union hub where all product components for the EU markets enter and are processed into final products. The office is responsible for compliance with all regulations prior to launch and organizes reliable and efficient logistics for our distributor network.
Lepzi China is located in Shanghai and is the business core to manage production and direct sales and marketing operations to meet growing demand in the Chinese POCT field. We deliver high-quality products and diagnostic solutions with continuous efforts.
We strongly support the regulatory framework of the medical device industry. Our organisation is ISO 13485 registered, and our products are transitioning from IVDD to IVDR certification with certain products having NMPA registration in China*.
*Please refer to each product page for registration information.